Methods for improving health in humans

ABSTRACT

Embodiments of the invention generally relate to methods and supplements for improving the health of human beings.

TECHNICAL FIELD

Embodiments of the invention generally relate to methods and supplementsfor improving health in human beings.

BACKGROUND

The primary biological function of hGH includes stimulating growth, cellrepair and regeneration. Once the primary growth period of adolescenceconcludes, the primary function of hGH in adulthood becomes that of cellregeneration and repair, helping regenerate skin, bones, heart, lungs,liver and kidneys to their optimal, youthful cell levels. As is the casewith many of our other hormones or their pre-cursors, such astestosterone, estrogen, progesterone, DHEA and melatonin, hGH levelsdecline with age. Therapeutically, many of these hormones can bereplaced to offset some of the effects of aging such as menopausalsymptoms in women or erectile dysfunction in men.

The human body, like every other living entity, works on daily, orcircadian, as well as monthly and annual rhythms. Daily growth hormonesecretion diminishes with age with roughly half the levels at age fortythat we had when we were twenty, and about one-third of those youthfullevels at age sixty. In some sixty-year olds, the levels are as low as25% of the hGH levels in a twenty-year old. Symptoms of aging includeloss of muscle, increase of fat, decreased physical mobility, decreasedenergy levels and as a result, diminished socialization, diminishedhealing ability and an increased risk of cardiovascular disease anddecreased life expectancy. Low hGH levels are associated with the agingprocess and early onset of disease. For example, Rosen and Bengtssonnoted an increased death rate from cardiovascular disease in hGHdeficient patients. (Rosen, T., Bengtsson, B. A., Lancet 336 (1990):285-2880)

Until recently human growth hormone (hereinafter alternatively referredto as hGH) was available only in expensive injectable forms, andbenefits from the restoration of hGH levels available only to those withthe ability to pay. Most recently substances that can trigger therelease of human growth hormone from an individual's own anteriorpituitary gland have become available. These are generically referred toas secretagogues. Secretagogues have the ability to restore hGH levels,potentially to the levels found in youth. See, e.g., “Grow Young WithhGH” by Dr. Ronald Klatz, President of the American Academy ofAnti-Aging, published in 1997 by Harper Collins.

HGH-deficient adults have marked reductions in lean body mass, andwithin months of hGH treatment, gains in lean body mass, skin thicknessand muscle mass are observed. (Cuneo R C et al. J Appl Physiol 1991;70:695-700; Cuneo R C et al. J Appl Physiol 1991; 70:688-694; Rudman Det al. N Engl J Med 1969; 280:1434-1438).

It is well-established that intravenous (IV) administration of someamino acids results in significant hGH secretion. Intravenous infusionof 183 mg of arginine/kg body weight in females increased hGHlevels >20-fold and 30 g of arginine elevated serum hGH levels 8.6 foldin males (Merimee T J et al. N Engl J Med 1969; 280:1434-1438; Alba-RothJ et al. J Clin Endocrinol Metab 1988; 67:1186-1189). Other amino acids,such as methionine, phenylalanine, lysine, histidine, and ornithine havealso led to marked increases in hGH (Alba-Roth, Muller, Schopohl, & vonWerder, 1988; Chromiak & Antonio, 2002; Gourmelen, M., M. Donnadieu, etal. (1972) Ann Endocrinol (Paris) 33(5): 526-528).

Given the difficulties in IV administration of amino acids forwidespread use, interest in elucidating the hGH response to oral aminoacid supplements prompted testing of such supplements containing mainlyarginine, lysine and ornithine at varying amounts. Yet the pronouncedvariability in results among these studies, which differed in aspectsincluding subject population, supplement composition, and dosagemethodologies, make clear the complexities involved in the design of aneffective supplement for supporting hGH levels in the general public.(Suminski R R et al. Int J Sport Nutr 1997; 7:48-60; Lambert M I et al.Int J Sport Nutr 1993; 3:298-305; Corpas E et al. J Gerontol 1993;48:M128-M133; Isidori A et al. Curr Med Res Opin 1981; 7:475-481;Fogelholm G M et al. Int J Sport Nutr 1993; 3:290-297; Chromiak J A,Antonio J. Nutrition 2002 July; 18(7-8):657-61).

Thus determination of an effective and safe oral functional blend thatstimulates hGH secretion in the general population is important todetermine since athletes, entertainers and now the general public seekeffective hGH support supplements and understand hGH to haverejuvenating properties.

Indeed, once partial to athletes and entertainers, the desire foreffective supplements to provoke growth hormone (hGH) increases nowextends to the general public. Not only do they have a goal of buildinglean tissue and reducing fat, but also in improving skin quality andother rejuvenating qualities that hGH is understood to provide. Despiteproceeding literature on oral amino acids for use in stimulating hGH,evidence for an optimized oral amino acid-containing blend able tostimulate hGH in the general public including both men and women of awide age range is not clear.

It would be desirable to provide a nutritional supplement for elevatinghGH release, in particular an amino acid-containing composition that iswell tolerated having the result of increasing or elevating hGH releasein those individuals whose hGH release rates have slowed as a functionof increasing age or that have normal hGH levels but desire higher hGHlevels. Although some existing nutritional supplements claim to impactthe production of natural human growth hormone, there is a need for animproved nutritional supplement that efficiently enhances the productionand effect of natural human growth hormone in the general population.

BRIEF SUMMARY OF THE INVENTION

Described herein are nutritional supplement and method of using thesame. The nutritional supplement includes an amino acid secretagoguecomposition, which, taken orally, stimulates the pituitary gland torelease hGH.

Some embodiments include an oral nutritional supplement that comprisesL-arginine, oxo-proline, and L-lysine.

Another particular embodiment relates to an oral nutritional supplementthat consists essentially of L-arginine hydrochloride, Oxo-proline,L-lysine hydrochloride, N-acetyl-L-cysteine, L-glutamine; andschizonepeta powder.

Other embodiments are drawn to methods of increasing human growthhormone in humans that include orally administering the disclosednutritional supplement to a human being to improve health, including:increasing lean body mass; reducing obesity, adipose tissue mass, andanxiety; supporting weight loss; decreasing appetite and atrophicprocesses in skeletal muscle, liver, kidney, spleen, skin, and bone; andimproving energy, endurance, sleep, metabolism, heart rate, bloodpressure, cardiovascular health, sympathetic nervous activity, thyroidresponse, glucose utilization, mental/cognitive function, reaction time,bone density, hair health and appearance, nail health and appearance,skin health and appearance, and libido.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows growth hormone levels after supplement administrationcompared to a placebo;

FIG. 2 shows a linear regression analysis of time to fall asleep withcontinued use of the supplement over time; and

FIG. 3 shows time awake during sleep over time with continued use of thesupplement.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a nutritional supplement for use by ahuman being. The present invention is drawn to a nutritional supplementand method of using the same. The nutritional supplement is an aminoacid secretagogue composition, which, taken orally, stimulates thepituitary gland to produce hGH. Increased production of hGH may resultin inhibition of insulin depression; inhibition of hyperglycaemia andincrease in insulin effectiveness; enhancement of fat conversion;lowering of cholesterol; normalization of lipid balance. The supplementof the present invention works as a dietary supplement by assisting thebody's own ability to secrete hGH naturally in a manner which is safeand effective, as well as being affordable.

A particular embodiment of the present disclosure relates to an oralnutritional supplement that includes l-lysine, l-arginine, oxo-proline,and one of either cysteine or glutamine. The supplement may additionallyinclude both cysteine and glutamine and/or schizonepeta powder. Inparticular embodiments, a functional dosage includes the l-arginine at alevel between 0.1-6 mmol and the oxo-proline between 0.1-8 mmol, and/orthe l-lysine in an amount between 0.1-12 mmol. The cysteine and/orglutamine may be contained at a level between 0.001-6 mmol. The cysteinecan be n-acetyl L-cysteine and the glutamine may be l-glutamine. Theamino acids may be delivered as non-toxic salts thereof, effectivecomplexes thereof, stable chelates thereof, active esters thereof,functional derivatives thereof, and mixtures thereof which are effectiveto increase hGH levels in the general population. The nutritionalsupplement may be present in an amount of 2.9 grams. The nutritionalsupplement may be in any acceptable and known oral formulation, such aspowder, tablet, capsule, liquid, or wafer form.

Another particular embodiment relates to an oral nutritional supplementthat consists essentially of l-lysine HCl, l-arginine HCl, oxo-proline,N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts)powder. In particular embodiments, a functional dosage includes thel-arginine HCl at a level between 0.1-6 mmol and the oxo-proline between0.1-8 mmol, and/or the l-lysine HCl in an amount between 0.1-12 mmol.The n-acetyl L-cysteine and/or l-glutamine may be contained at a levelbetween 0.001-6 mmol. In another particular embodiment, a functionaldosage includes the l-arginine HCl at a level between 2.5-4.5 mmol andthe oxo-proline between 4-6 mmol, and/or the l-lysine HCl in an amountbetween 7-9 mmol. The n-acetyl L-cysteine and/or 1-glutamine may becontained at a level between 0.001-0.5 mmol. The nutritional supplementmay be in any acceptable and known oral formulation, such as powder,tablet, capsule, liquid, or wafer form.

Other embodiments are drawn to methods of increasing human growthhormone in humans that include orally administering the disclosednutritional supplement to a healthy human being. As used herein,“healthy human being” means a human being having any age-related declinein hGH, and excluding any physiological deficiency that is not agerelated. Particular embodiments of the invention relate to oraladministration of the disclosed nutritional supplement to a human thatis at least 30 years old. The nutritional supplement may be administeredfrom one to three times daily or, alternatively, may be administeredevery other day, or may be administered once a week. In particularembodiments, the nutritional supplement may be administered on an emptystomach.

The disclosed nutritional supplements can be orally administering to ahuman being to improve health, including by: increasing lean body mass;reducing obesity, adipose tissue mass, and anxiety; supporting weightloss; decreasing appetite and atrophic processes in skeletal muscle,liver, kidney, spleen, skin, and bone; and improving energy, endurance,sleep, metabolism, heart rate, blood pressure, cardiovascular health,sympathetic nervous activity, thyroid response, glucose utilization,mental/cognitive function, reaction time, bone density, hair health andappearance, nail health and appearance, skin health and appearance, andlibido.

More specifically, oral administration of the disclosed nutritionalsupplements can improve hair and/or nail thickness, length, and growth.Oral administration of the disclosed nutritional supplements can improvewound healing, provide anti-aging skin properties, and reduction inwrinkles, dark spots, discolorations, dullness, sagging, laxity, andthinning, and can further improve texture, luminosity, “lift,” tone,radiance, smoothness, uniformity, and youthful look of skin. Thedisclosed nutritional supplements can also be used in combination withtestosterone or testosterone-boosting supplements to enhance the effectof the nutritional supplements disclosed herein.

In accordance with the “consist essentially of” and “consistingessentially of” language, the nutritional supplement of the thirdembodiments is essentially limited to the aforementioned ingredients anddoes not include any additional active ingredients intended to addnutritional content (e.g., vitamins, minerals, etc.), but may includeadditional ingredients not intended to add nutritional content such asingredients intended to fulfill a non-nutritional purpose (e.g.,coloring, fillers, flavoring, an ingredient for maintaining thestructural form, etc.).

Each ingredient of the nutritional supplement of the present inventionmay be prepared in accordance with any method known to one of ordinaryskill in the art. Alternatively, each ingredient may be obtained in afully prepared from a commercially available source.

The nutritional supplement of the present invention may be in anysuitable oral administration form, including but not limited to: achewable form, a liquid form, a spray form, a capsule form, asuppository form, dissolvable wafer, and a powder form.

Irrespective of the structural form of the nutritional supplement, theingredients of the nutritional supplement may be distributedhomogeneously or nonhomogeneously within the nutritional supplement.

The nutritional supplement of the present invention may be ingested on aregular basis, such as a daily or weekly intake at a dosage tailored toan individual's needs; i.e., the nutritional supplement is to be takenregularly as multiples (1×, 2×, etc.) of the structural units (pills,tablets, capsules, etc.) in accordance with the needs of the individual.For example, a senior citizen leading a sedentary life is likely to needhigher daily doses than does a young person engaged in regular strenuousexercise (e.g., a weight lifter). Alternatively, the nutritionalsupplement of the present invention may be ingested on an as-neededbasis at a dosage tailored to the individual's needs. Medical ornutritional counseling may be beneficial for arriving at a desirable oroptimal dosage tailored to the individual's needs.

The combination of types of amino acids, mass ranges, and specificformulations have been selected to be synergistically balanced and ofadequate quantity to achieve the desired physiological effect, namely,growth hormone release. Improper combinations of the amino acids may beineffective. The component amino acids are synergistic in the sense thatseveral of them when combined together, synergistically stimulate therelease of human growth hormone. The combination was also chosen toreduce or inhibit chemical combination or reaction between the aminoacids.

EXAMPLES Example 1

The short-term effects of a single oral nutritional supplement on hGHlevels 2 hours post ingestion was studied 16 healthy subjects [12 males,4 females; 9 Caucasian, 6 African American, 1 other; mean age=32±14years; body mass index=26.4 t 5.0 ranging from 19.1 to 36.8 kg/m²]. Eachsubject reported to the Inpatient Unit on two occasions one week apart.After an overnight fast, subjects had an IV line placed and baselinebloods samples were drawn at −30, −15, and 0 minutes.

Subjects were then asked to swallow the capsules of supplement(SeroVital™) or an identical looking placebo. SeroVital™ is a 2.9 g/doseblend of l-lysine HCl, l-arginine HCL, oxo-proline, N-acetyl-l-cysteine,l-glutamine, and schizonepeta (aerial parts) powder. Blood was drawn at15, 30, 60 and 90 and 120 minutes for assay. Human GH was measured ateach time point using the Siemens Immulite 2000 (intra-assay CV was3.72%, inter-assay CV was 5.70%, and the detection limit for GH was 0.05ng/ml. The −15 and 120 minute time points were additionally assayed fortriiodothyronine (T3) as informative for mechanistic investigations.

The mean growth hormone increased 682% after the supplement from 0.17 atbaseline to 1.33 ng/ml at 120 minutes compared to a mean decrease of 52%after the placebo from 0.93 to 0.45 ng/ml (FIG. 1).

The mean change in GH levels from baseline to 120 minutes (GH at 120minutes minus GH at 0 minutes), was 1.15 (95% CI: 0.17, 2.14) ng/mlafter the supplement versus −0.48 (−1.47, 0.50) ng/ml after the placebo,demonstrating a statistically significant differential effect (P=0.01).After the supplement, the mean AUC for GH across 120 minutes was 20.43(95% CI: 19.90, 20.95) ng/ml/min which was significantly higher (P=0.04)than placebo at 19.67 (18.74, 20.59) ng/ml/min. Overall, 120 minutesafter taking the supplement, GH levels were significantly higher inabsolute levels or by AUC.

As daily circadian levels of T3 naturally decrease during the morninghours, at which the current trial was scheduled, it was not surprisingthat placebo levels between the −15 and 120 minute time points decreasedby −6.10 ng/dL (106 to 100 ng/dL, P=0.01). In contrast, the SeroVital™group exhibited a deceased reduction in T3 by nearly one-half over thesame time course, −3.3 ng/dL (101-97.3 ng/dL, NS), which was not asignificant reduction compared to baseline, as was the reduction in theplacebo group. These results affirm that somatostatin inhibition plays amechanistic role in the ability of SeroVital™ to induce significantincreases in serum GH levels in human subjects.

At 120 minutes, GH concentrations were 2-fold higher in women (2.3±1.1ng/ml, n=4) than in men (1.0±0.4 ng/ml, n=12, although the study was notadequately powered for these comparisons. Nevertheless, these findingssupport an enhanced effect of the SeroVital™ supplement in women.

An eight-fold increase was observed, equivalent to 682%, in GH levels120 minutes after a single oral supplement of SeroVital™. The study hada broad range of ages and BMI's and included both genders. An additionaladvantage of the present study over previous GH evaluations is that itcontained a placebo control group and was randomized and double-blinded.

These findings demonstrate that a specialized low-dose amino acidsupplement can significantly increase short-term GH levels. Futurestudies will examine whether such increases in GH with oral amino acidsupplementation increase fat-free mass and strength. This indeed may bethe case, since elderly subjects administered oral GH secretagogues for6 and 12 months have sustained increases in lean body mass and improvedphysical function.

The absolute magnitudes of these results are somewhat difficult todirectly correlate among past studies, as commercial GH assays usedifferent antibodies to target specific GH epitopes. Therefore,different antibodies and assays are less likely to recognize somespecific isoforms and fragments of the GH molecule. This results invariability of the normal range of the GH measurements in differentassays. Indeed, the same GH sample measured using different assays canvary 2-3 fold, limiting the ability to compare actual GH levels acrossstudies. Nevertheless, the mean levels of GH reached after thesubcutaneous injection of 0.06 IU of HGH in the treatment of GHdeficient subjects was 0.4 ng/ml, a value that was clearly in the rangeof values seen in our study with oral amino acids.

Findings obtained from a randomized, blinded, placebo-controlled studystrengthen the evidence that oral administration of amino acids, whencompounded properly, can increase GH serum levels, wherein SeroVital™administration showed an 8-fold, equivalent to a 682% increase in GHlevels 120 minutes after a single oral dose. In addition, we elucidatesome mechanistic details for these significant GH increases as throughsomatostatin inhibition, supported by our results on the 120 minuteresults on T3 levels in the same subjects.

Example 2

To test the effect of the nutritional supplement on endurance and fatmetabolism, a double-blind clinical study was conducted involving 12healthy subjects [7 males, 5 females; mean age=31±6 years; body massindex=25.7±3.8 ranging from 20.3 to 32.2 kg/m²]. Each subject reportedto the Fitness Testing Facility (PEAK, University of Utah College ofHealth) after an overnight fast. Upon arrival each subjects underwentstandard measurements of weight, height, body fat percent (Bod Pod), andresting metabolic rate (RMR, indirect calorimerty). Daily calorieexpenditure was estimated based on the additive evaluations of measuredRMR, estimated Lifestyle and Activity (defined as the number of caloriesburned performing daily activities including working, playing eating,etc), and estimated Exercise (defined as an estimate of the number ofcalories burned during exercise based on daily activity level).Following the baseline measurements, subjects then consumed a standardbreakfast (Egg McMuffin, 300 Calories; 12 g fat; 29 g carbohydrates; 18g protein). Subjects rested for a further 45 min to reach apost-absorptive state, then underwent a Maximal Aerobic Fitness Test ofgraded exercise, completed on a treadmill. Subjects' oxygen uptake wasmeasured using a metabolic cart, and VO_(2max) was quantified.

Subjects were then provided a two week supply of a novel supplementSeroVital (2.9 g/dose blend of l-lysine HCl, l-arginine HCl,oxo-proline, N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerialparts) powder). The novel SeroVital blend has been shown previously toincrease serum human growth hormone hGH levels by 8 times (equivalent to682%) 120 minutes after a single dose in healthy male and femalevolunteers. In this study, subjects were instructed to consume one doseof the supplement on an empty stomach, two hours after dinner prior tobedtime, every night for the two-week study duration. Following thefinal dose, each subject returned to the PEAK Fitness Testing Facility,University of Utah College of Health after an overnight fast (withouthaving consumed their last dose of the supplement since the previousnight). Upon arrival each subjects underwent the identical testprotocols as the baseline test day. The data from the two measurementdays were then analyzed. Consistent with our priori hypothesis that thesupplement would increase improve endurance parameters with its abilityto increase in hGH levels, the decision was made to reject the null onlyif the data supported the one directional alternative consistent with afavorable response to the supplement. Statistical significance wasassumed for P≦0.05.

Mean VO_(2max) increased by 6% from 44.9±8.1 at baseline to 47.7±9.2mL/kg/min (3.69±0.96 to 3.91±1.02 L/min), demonstrating a statisticallysignificant differential effect compared to baseline (P=0.02). After theperiod of supplementation with SeroVital, the mean RMR increased by 2.7%from 1687±330 to 1733±288 kcal/day with a statistical trend towardssignificance compared to baseline (P=0.165). Estimated daily calorieexpenditure also increased by 2.7% from 1687±330 to 1733±288 kcal/daywith trend towards significance (P=0.166).

After two weeks of supplementation with the supplement SeroVital, (takenon an empty stomach, two hours after dinner prior to bedtime, everynight), both RMR and estimated daily calorie expenditure tended toincrease, evidencing the potential of the supplement to impart long-termfat burning effects. Additionally, endurance as measured by VO_(2max) inthe post-absorptive state significantly improved with a measured 6%increase. Overall, the SeroVital supplement was shown to increaseparameters of endurance, energy, and vitality.

Example 3

To test the ability of the nutritional supplement to improve sleep, adouble-blind clinical study was conducted involving 15 healthy subjects[10 males, 5 females; mean age=33±7 years]. Each subject completed abaseline Epworth Sleepiness Scale self-report questionnaire and astandardized assay of usual sleep habits. All subjects were deemed tohave average sleep parameters within a normal range.

The subjects were then provided a three week supply of a novelsupplement SeroVital (2.9 g/dose blend of l-lysine HCl, l-arginine HCl,oxo-proline, N-acetyl-l-cysteine, 1-glutamine, and schizonepeta (aerialparts) powder). The novel SeroVital blend has been shown previously toincrease serum human growth hormone hGH levels by 8 times (equivalent to682%) 120 minutes after a single dose in healthy male and femalevolunteers. Because night-time onset of hGH has been directly correlatedto sleep efficiency, we investigated sleep patterns with continued useof the supplement when taken on an empty stomach, two hours after dinnerprior to bedtime, every night for three weeks. On each trial day,subjects reported 1) time went to bed; 2) time of final wakening; 3)estimated time to fall asleep; 4) time of awakening during sleep/lengthof time awake. Data was compiled by day for estimated time to fallasleep and length of time awake during sleep in order to assess sleepefficiency. Daily values for each measure were plotted as an average(±S.D.) among the subjects over the time course of the study, and alinear regression was tabulated to assess overall trends over time. Allavailable data was included in the analysis.

Linear regression analysis showed that both estimated time to fallasleep (FIG. 2) and time awake during sleep (FIG. 3) tended to decreaseover time with continued use of the supplement over the time course ofthe study. Time to fall asleep decreased with an average slope of −0.24min/day, and time awake during sleep decreased by an average slope of−0.26 min/day. Overall, these results so a trend towards greater sleepefficiency by measurements of both time to fall asleep and time awakeduring sleep, both with a quantified average decrease of about 0.25min/day over three weeks with regular nighttime use of the novelSeroVital supplement (when taken as directed, on an empty stomach, twohours after dinner prior to bedtime).

Example 4

To test the effect of the nutritional supplement on lean body mass andweight change of humans, healthy men and women between the ages of 30 to80 years are recruited through advertisements. Standardized assessmentcriteria are used to select subjects at risk for functional decline(e.g., hand grip strength, habitual gait speed, etc.). Additionally,subjects are excluded for diabetes mellitus, use of anticoagulants,seizure disorder, cancer treatment within five years, poorly controlledhypertension, unstable or recent onset angina, myocardial infarctionwithin 6 months, cognitive impairment, depression, significantlimitations of lower extremity function, bradycardia, systolic bloodpressure <100 or >170 mm Hg, or orthostatic hypotension. Subjectsparticipating in strength training programs were also excluded.

Subjects are given daily doses of the nutritional supplement for 6months at different dosing concentrations of active ingredients, and onegroup is treated as a placebo group. The study includes a pre-screeningassessment, screening and baseline visits, and weekly visits over theplanned 6 months, where weight, body composition, and physicalperformance (including endurance) are determined, along with hormonaldata analysis. Weight, percent lean body mass, and percent fat body massare chosen as primary measures of body composition at the 6 monthanalysis period.

Example 5

To test the effect of the nutritional supplement on energy, bonedensity, skin thickness, and mass of adipose tissue of healthy men over60 years old are recruited through advertisements. Standardizedassessment criteria are used to select subjects at risk for functionaldecline (e.g., hand grip strength, habitual gait speed, etc.). Entrycriteria includes body weight of 90 to 120 percent of the standard forage. Additionally, subjects are excluded for diabetes mellitus, use ofanticoagulants, seizure disorder, cancer treatment within five years,poorly controlled hypertension, unstable or recent onset angina,myocardial infarction within 6 months, cognitive impairment, depression,significant limitations of lower extremity function, bradycardia,systolic blood pressure <100 or >170 mm Hg, or orthostatic hypotension.Subjects participating in strength training programs were also excluded.

Subjects are given daily doses of the nutritional supplement for 6months at different dosing concentrations of active ingredients, and onegroup is treated as a placebo group. The study includes a pre-screeningassessment, screening and baseline visits, and weekly visits over theplanned 6 months, where lean body mass, mass of adipose tissue, skinthickness, and bone density at various skeletal sites are measured.Subjects are also monitored for changes in energy levels throughout theexperiment.

Example 6

To test the effect of the nutritional supplement on anxiety and sleep,healthy men and women between the ages of 30 to 80 years are recruitedthrough advertisements. Subjects are interviewed by a psychiatrist usingthe Structured Clinical Interview for DSM-III-R or analogous method.Patients are all drug free. The study focuses on the evaluation ofanxiety, sleep patterns, and measurement of basal morning stress hormonelevels at various points during the 6 month testing period.

Subjects are given daily doses of the nutritional supplement for 6months at different dosing concentrations of active ingredients, and onegroup are treated as a placebo group. The study includes a pre-screeningassessment, screening and baseline visits, and weekly visits over theplanned 6 months, where anxiety assessment (e.g., Hamilton AnxietyRating Scale), and anxiety and stress hormone levels (e.g., cortisol andGH) are determined, and sleep study analysis are conducted.

While embodiments of the present invention have been described hereinfor purposes of illustration, many modifications and changes will becomeapparent to those skilled in the art. Accordingly, the appended claimsare intended to encompass all such modifications and changes as fallwithin the true spirit and scope of this invention.

We claim:
 1. A method of increasing hGH, increasing endurance,increasing fat metabolism, improving sleep, reducing anxiety, andimproving lean body mass in a human being, comprising: providing an oralnutritional supplement, consisting essentially of: about 1 mmolL-arginine: about 1 mmol Oxo-proline; about 2 mmol L-lysine: about 1.5μmol N-acetyl L-cysteine; about 2 μmol L-glutamine; and about 125 μgSchizonepta (aerial parts) powder; and orally administering thenutritional supplement to the human being in an amount effective to:increase hGH, increase endurance, increase fat metabolism, improvesleep, reduce anxiety, or improve lean body mass.
 2. The method of claim1, wherein the nutritional supplement is present in an amount of 2.9grams.
 3. The method of claim 1, wherein the nutritional supplement isin powder, tablet, capsule, liquid, or wafer faun.
 4. The method ofclaim 1, wherein the nutritional supplement is administered from one tothree times daily.
 5. The method of claim 1, wherein the nutritionalsupplement is administered once a week.
 6. The method of claim 1,wherein the nutritional supplement is administered on an empty stomach.7. The method of claim 1, wherein the human being is at least 30 yearsold.
 8. A method of increasing hGH, increasing endurance, increasing fatmetabolism, improving sleep, reducing anxiety, and improving lean bodymass in a human being, comprising: providing an oral nutritionalsupplement, consisting essentially of: 3.44 mmol L-arginine; 5.30 mmolOxo-proline; 8.21 mmol L-lysine; 6.13 μmol N-acetyl L-cysteine; 6.84μmol L-glutamine; and 0.50 mg Schizonepta (aerial parts) powder; andorally administering the nutritional supplement to the human being in anamount effective to: increase hGH, increase endurance, increase fatmetabolism, improve sleep, reduce anxiety, or improve lean body mass. 9.The method of claim 8, wherein the nutritional supplement is present inan amount of 2.9 grams.
 10. The method of claim 8, wherein thenutritional supplement is in powder, tablet, capsule, liquid, or waferform.
 11. The method of claim 8, wherein the nutritional supplement isadministered from one to three times daily.
 12. The method of claim 8,wherein the nutritional supplement is administered once a week.
 13. Themethod of claim 8, wherein the nutritional supplement is administered onan empty stomach.
 14. The method of claim 8, wherein the human being isat least 30 years old.